TICE BCG Rx

Indications for TICE BCG:

Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. Prophylaxis of stage Ta and/or T1 papillary tumors following transurethral resection (TUR).

Adult:

1 vial in 50mL preservative-free saline intravesically once per week for 6 weeks (may repeat this regimen once if remission not achieved); then monthly for 6–12 months if needed. Avoid fluid at least 4hrs before treatment and void immediately before administration. Retain in bladder for 2hrs.

Children:

Not recommended.

Contraindications:

Immunosuppressed. Active TB. Febrile illness. UTI. Gross hematuria. Do not give within 7 days after bladder biopsy, TUR, or traumatic catheterization.

Boxed Warning:

Prepare, handle, and dispose of as a biohazard material. BCG infections. Nosocomial infections.

Warnings/Precautions:

Not a vaccine for prevention of cancer or TB. Not for IV or SC inj use. Determine PPD status prior to therapy; rule out active TB if (+). Monitor for signs of systemic BCG infection: flu-like symptoms >72 hrs, fever ≥103°F, persistent LFT abnormalities; prostatitis, epididymitis, orchitis >2 days; treat with at least 2 antimycobacterial drugs (except pyrazinamide). High risk for HIV infection. Local irritative toxicities: do not treat with antimycobacterials. Bleeding bladder mucosa, small bladder. Disinfect fluid voided after therapy with bleach. PPD seroconversion may occur with treatment. Pregnancy, nursing mothers: not recommended.

Pharmacological Class:

BCG Live.

Interactions:

Immunosuppressants, myelosuppressants, radiation, antimicrobial therapy may reduce efficacy.

Adverse Reactions:

Dysuria, urinary frequency, urgency, flu-like syndrome, hematuria, fever, malaise/fatigue, cystitis, bladder irritation, inflammation (begins after 4 hrs and last up to 72 hrs), chills, systemic BCG infection, nocturia, cramps, pain, incontinence, rigors, arthralgia.

How Supplied:

Vial—1